FDA clears a FloSpine 510(k) for its a 3D-printed titanium Ti-Largo cervical interbody cage system to support the spine after a cervical collapse or a...
FDA cleared a Convatec 510(k) for its InnovaMatrix PD particulate placental extracellular matrix medical device for wound management.
FDA publishes the CDER Drug Safety 2002 Priorities Report reviewing the many drug safety activities the Center undertook in 2022.
CDER director Patrizia Cavazzoni describes how FDA and FTC are working collaboratively to increase competition for biologic products.
Federal Register notice: FDA announces a 4/28 Oncologic Drugs Advisory Committee meeting to review an AstraZeneca supplemental NDA for Lynparza (olapa...
The Sedgwick 2022 recall report says both drug and medical device recall events surged higher in 2022, with drugs outpacing devices.
FDA releases the form FDA-483 with eight observations from an inspection at the Madhya, Pradesh, India-based Cipla facility that manufactures sterile ...
A Reuters investigative report relying on anonymous sources says FDA has rejected an application from Elon Musks Neuralink to open human trials of its...
